Aseptic Technique and Garbing Flashcards

During aseptic manipulations inside a horizontal LAFW, where should the technician position their hands relative to the CSP components?

Answer: Behind the components (downstream)

In a horizontal LAFW, air flows from the HEPA filter at the back toward the technician. Hands should be positioned downstream to avoid disrupting first air.

What is the maximum allowable particle count (0.5 micron or larger) per cubic meter in an ISO Class 5 environment?

Answer: 3,520

An ISO Class 5 environment allows a maximum of 3,520 particles of 0.5 microns or larger per cubic meter.

Which garbing item must be replaced if it becomes visibly soiled or torn during a compounding session?

Answer: Any garbing item that is soiled or compromised

Any individual garbing item that becomes visibly soiled, torn, or otherwise compromised must be replaced immediately.

What type of fingernail policy is required for personnel performing sterile compounding?

Answer: Natural nails trimmed short; no artificial nails or extenders

USP 797 requires that compounding personnel keep natural nails trimmed short and prohibits artificial nails, extenders, and nail polish.

When performing a media-fill test, what is being evaluated?

Answer: The technician aseptic technique and the compounding environment

A media-fill test evaluates the technician aseptic technique and the suitability of the compounding environment by using growth media instead of actual drugs.

What is the minimum frequency for viable air sampling in the ISO Class 5 PEC during compounding operations under USP 797?

Answer: Every 6 months

Under USP 797, viable air sampling in the ISO Class 5 PEC is required at minimum every 6 months as part of the ongoing environmental monitoring program.